Status : Published (Under review)

This standard was last reviewed and confirmed in 2018. Therefore this version remains current.
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Abstract

ISO 15198:2004 describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers' claims. ISO 15198:2004 applies to all in vitro diagnostic medical devices.

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General information

  • Status
     : Published
    Publication date
     : 2004-07
    Stage
    : Close of review [90.60]
  • Edition
     : 1
    Number of pages
     : 10
  • Technical Committee :
    ISO/TC 212
    ICS :
    11.100.10 
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